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EC number: 208-909-6 | CAS number: 546-68-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data obtained from peer-reviewed publication.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Remarks:
- Conducted in compliance with the Toxic Substances Control Act (TSCA) Good Laboratory Paractices Standards (U.S. EPA, 1989a)
- Limit test:
- no
Test material
- Reference substance name:
- Propan-2-ol
- EC Number:
- 200-661-7
- EC Name:
- Propan-2-ol
- Cas Number:
- 67-63-0
- Molecular formula:
- C3H8O
- IUPAC Name:
- propan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): isopropanol (isopropyl alcohol)
- Physical state: colorless liquid
- Analytical purity: 99.95+/-0,01%
- Storage condition of test material: refrigerated
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA
- Age at study initiation: 5.5 months
- Weight at study initiation: 2750 to 3800 g
- Fasting period before study: not reported
- Housing: singly in stainless steel cages with mesh flooring (Hoeltge, Inc., Cincinnati, OH)
- Diet (e.g. ad libitum): #5322 Purina Certified Rabbit Chow ad libitum
- Water (e.g. ad libitum): deionized/filtered tap water ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.3 to 20.6 °C
- Humidity (%): 48.4 to 54.4%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionized/distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Study dosing solutions were formulated at 0.0, 60.0, 120.0 and 240.0 mg/mL, corresponding 0.0, 120.0, 240.0 and 480.0 mg/kg/day at a dosing volume of 2.0ml/kg.
Amount of vehicle: 2ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration of dosing formulations were confirmed by gas chromatography (Hewlet Packard 5890A), with a 30mm x 0,32mm (i.d) capillary column. All formulations were within 97.1-106% of target concentration
- Details on mating procedure:
- - Impregnation procedure: artificial insemination
- Duration of treatment / exposure:
- From day 6 to 18 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- On gestation day (GD) 0 animals were distributed into groups. Test material was administered during GD 6 through GD 18. On GD 30 maternal animals were euthanized/necropsied and embryo/fetal observations were performed
- No. of animals per sex per dose:
- A total of 15 females per dose were treated; two females in the 120 mg/kg bw/day dose group were not pregnant at sacrifice.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The doses for the range-finding study in pregnant rabbits were 0, 312.5, 625, 1250 mg/kg bw/day, 10 inseminated does per group. All does at 1250mg/kg/day died or were were euthanized moribund by GD8. Seven does at 625 mg/kg/day died or were euthanized moribund by GD 12. There was no observable maternal or developmental toxicity at 312 312.5mg/kg/day. The highest dose level was chosen to induce overt maternal toxicity, but not to cause a weight loss greater than 20% when compared to concurrent controls, nor to cause greater than 10% maternal mortality. The low dose was selected to be a maternal/developmental no-observable-adverse-effect level (NOAEL). The mid-dose was halfway between the high and low doses.
- Rationale for animal assignment (if not random): Animals were assigned to treatment groups by a stratified randomization method designed to provide uniform mean body weights across dose groups at the initiation of the study.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least once daily on gestation days 0-5 (prior to dosing) and 19-30 (after dosing period); twice daily at dosing and 1-2 hours after dosing, throughout the dosing period (gestation days 6 through 18).
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: gestation days 0, 6, 9, 12, 15, 18, 24, and 30.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: not applicable
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 30
- Organs examined: thoracic and abdominal cavities, maternal body, liver and uterus weights recorded. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: dead and live fetuses - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: half per litter - Statistics:
- Parametric statistical procedures were applied to selected measures from this toxicity study. Appropriate General Linear Models (GLM) procedures (SAS Institute Inc., 1985a, 1985b) for the proposed Analyses of Variance (ANOVA) were employed. Prior to GLM analysis, an arcsine-square root transformation was performed on all litter-derived percentage data (Snedecor and Cochran, 1967) and Bartlett’s test for homogeneity of variance (alpha level = 0.001) was performed on all data to be analyzed by ANOVA (Winer, 1962). GLM analysis was used to determine the significance of the dose-response relationships (Test for Linear Trend), and to determine whether significant dose effects had occurred for selected measures (ANOVA). When a significant (p<0.05) main effect for dose occurred, Williams’ Multiple Comparison Test (Williams, 1971; 1972) and/or Dunnett’s Multiple Comparison Test (Dunnett, 1955; 1964) was used to compare each exposed group to the vehicle control group for that measure. A one-tailed test (i.e., Williams’ Test and/or Dunnett’s Test) was used for all pairwise comparisons except that a two-tailed test was used for maternal body and organ weight parameters, maternal food consumption, fetal body weight, and percent males per litter. Nominal scale measures were analyzed by Chi-Square Test for Independence for differences among treatment groups, and by a test for linear trend on proportions (Snedecor and Cochran, 1967). When Chi-Square revealed significant (p<0.05) differences among groups, then a one-tailed Fisher’s Exact Probability Test was used for pair wise comparisons between each treated group and the vehicle control group.
- Indices:
- Dams: pregnancy; corpora lutea; implantation sites per litter; percent preimplantation loss; live fetuses per litter; total and percent: resorptions per litter, litters with resorptions, late fetal deaths per litter, litters with late fetal deaths, nonlive implants per litter, litters with nonlive implants, adversely affected implants per litter; male and female fetuses per litter; average fetal body weight per litter; average male fetal body weight per litter; and average female fetal body weight per litter.
- Historical control data:
- The designation of fetal alterations as malformations or variations was based on the literature and on historical control data in the performing laboratory.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
For does died at 480 mg/kg/day (4/15; 26,7%). Maternal body weight change was statistically significantly reduced at 480 mg/kg/day for GD 6-18 ( 45,5% of control value). Maternal food consumption was statisticaly significantly reduced at 480mg/kg/day. Corrected maternal gestational weight change (gestational weight change minus gravid uterine weight) was substantially reduced at 480 mg/kg/day relative to the control value. Furthermore, clear signs of treatment-related toxicity was observed in the 480mg/kg/day group. At 240 and 120mg/kg/day relatively mild and transient signs of toxicity were observed.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 240 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 480 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There was no demonstrable developmental toxicity at a dose resulting in significant maternal toxicity (480 mg/kg/day) or at doses with only relatively mild and transient clinical signs of toxicity (240 and 120 mg/kg/day).
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- There was no demonstrable developmental toxicity at a dose resulting in significant maternal toxicity (480 mg/kg/day) or at doses with only relatively mild and transient clinical signs of toxicity (240 and 120 mg/kg/day).
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Read-across justifications and data matrices are presented in IUCLID section 13.
Applicant's summary and conclusion
- Conclusions:
- Propan-2-ol was not teratogenic when administered orally during GD6-18 to rabbits. By the publication, the NOAEL for maternal toxicity was 240 mg/kg/day and the NOAEL for developmental toxicity was 480 mg/kg/day.
- Executive summary:
Possible prenatal developmental toxicity of propan-2 -ol in rabbits was evaluated in this study conducted according to U.S EPA guideline 40 CFR 798.4900 under U.S. EPA Good Laboratory Paractice (GLP) Standards.
Treatment with propan-2 -ol up to 240 mg/kg bw/day was well tolerated by the rabbits. Clinical signs, if any, at 120 and 240mg/kg/day is not clear; these signs were slight and transient and most probably indicators of stress. Maternal rabbits exhibited increased mortality, reduced weight gain and food consumption, and specific clinical signs at a 480mg/kg bw/day dose. There was no indication of developmental toxicity, even at a dose which resulted in 26,7% maternal mortality.
Based on test results, the following No Observed Adverse Effect Levels (NOAEL) were derived:
Maternal NOAEL: 240 mg/kg/day
Developmental NOAEL: 480 mg/kg/day
The results of this study would not lead to the classification for reproduction developmental toxicity according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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